MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and,
revision procedures where other treatments or devices have failed.

Device Description

The BIOLOX® delta Option and Extra-long Heads include femoral heads and neck sleeves. The design features are summarized below:

Femoral Heads
- BIOLOX® delta Option:
  - Manufactured from alumina matrix composite
  - Head sizes: 28mm, 32mm, 36mm, 40mm, 44mm
  - Conical Bore: 16/18 Taper
- BIOLOX® delta Extra-long:
  - Manufactured from alumina matrix composite
  - Head Sizes: 32mm, 36mm, 40mm
  - Conical Bore: 12/14 Taper
Neck Sleeves
- BIOLOX® delta Option:
  - Manufactured from titanium alloy
  - Neck Sleeve sizes: Short, Medium, Long, and Extra-long
  - Conical Bore: 16/18 External Taper, 12/14 Internal Taper

AI/ML Overview

The provided document describes a 510(k) premarket notification for the BIOLOX® delta Option and Extra-long Heads, which are components of total hip arthroplasty systems. Per the document, the device did not undergo clinical testing, and therefore, no acceptance criteria based on clinical performance metrics are provided. The clearance is based on substantial equivalence to predicate devices and non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence and non-clinical testing, specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in error rate) are not stated in the document. The non-clinical tests assess the physical and mechanical properties of the device. The document states that the safety and effectiveness are "adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." The reported "performance" for these non-clinical tests would typically be within the expected range for such devices and comparable to predicate devices, but the specific numerical results or acceptance thresholds are not detailed in this summary.

Acceptance Criteria Category	Reported Device Performance (Summary)
Mechanical Performance
Static (Pre-fatigue) Burst Strength	Evaluated (results not specified)
Post-fatigue Burst Strength	Evaluated (results not specified)
Taper System Stability
Axial Pull-off Test (Distraction Forces)	Evaluated (results not specified)
Rotational Stability (Torque)	Evaluated (results not specified)
Corrosion
Fretting Corrosion (Sleeve & Tapers)	Tested (results not specified)
Biocompatibility	Referencing Master File and predicate/reference devices (no new testing)
Component Compatibility	Compatible with listed MicroPort Orthopedics products (See Tables 1 & 2)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical testing. For these mechanical tests, the sample sizes are not specified, nor is the country of origin of the data mentioned. The data provenance is non-clinical (laboratory testing). No human test set data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document describes non-clinical testing of a hip implant device, not a diagnostic or AI-based device requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to the mechanical and biological safety of an orthopedic implant, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is based on established engineering principles and material science standards for evaluating the performance and safety of medical devices. For instance, burst strength tests have defined failure points based on material properties and structural integrity. For biocompatibility, the ground truth is established through validated testing methods outlined in international standards (e.g., ISO 10993) or by referencing previously cleared devices with known biological responses.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is a physical medical device, not an AI model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 6, 2018

MicroPort Orthopedics Inc. Allen Mamaril Regulatory Affairs Specialist I 5677 Airline Road Arlington, Tennessee 38002

Re: K173776

Trade/Device Name: BIOLOX delta Option and Extra-long Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO Dated: June 1, 2018 Received: June 4, 2018

Dear Allen Mamaril:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vincent J. Devlin -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K173776

Device Name BIOLOX® Delta Option and Extra-long Heads

Indications for Use (Describe)

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and,
revision procedures where other treatments or devices have failed.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with a red star inside, followed by the text "MicroPort" in blue and "Orthopedics" in red. Below the logo is the text "MicroPort Orthopedics Inc." in black.

510(K) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the BIOLOX® delta Option and Extra-long Heads.

Submitted by:	MicroPort Orthopedics Inc.5677 Airline Rd, Arlington, TN, 38002Phone 866-872-0211Fax: 855-466-2247
Date:	December 11, 2017
Contact Person:	Allen MamarilRegulatory Affairs Specialist I
Proprietary Name:	BIOLOX® delta Option and Extra-long Heads
Common Name:	Femoral Head, Neck Sleeve
Classification Name and Reference:	21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncementedprosthesis—Class II
Subject Product Code and Panel Code:	Orthopedics/87/LZO
Predicate Device:	Femoral Head:K130376 DYNASTY® Acetabular System with CeramicNeck Sleeve:K072656 DYNASTY® Acetabular System
Reference Device:	Femoral Head:K140043 DYNASTY® Acetabular System with CeramicK953025 SLT 28mm XXL Femoral HeadK141653 Biolox® delta Option Ceramic HeadsK131684 Biolox® delta Ceramic headsK131518 Mectacer Biolox Option HeadsK112115 Mectacer Biolox Delta HeadsNeck Sleeve:K141653 Biolox® delta Option Ceramic HeadsK131518 Mectacer Biolox Option Heads

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Image /page/4/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with a red star inside, followed by the text "MicroPort" in blue and "Orthopedics" in red. Below the logo, the text "MicroPort Orthopedics Inc." is written in a smaller font.

DEVICE INFORMATION

A. Intended Use

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
revision procedures where other treatments or devices have failed. 4.

B. Device Description

The BIOLOX® delta Option and Extra-long Heads include femoral heads and neck sleeves. The design features are summarized below:

Femoral Heads ●
- BIOLOX® delta Option: o
  - Manufactured from alumina matrix composite
  - Head sizes: 28mm, 32mm, 36mm, 40mm, 44mm ■
  - Conical Bore: 16/18 Taper
- BIOLOX® delta Extra-long: o
  - Manufactured from alumina matrix composite ■
  - Head Sizes: 32mm, 36mm, 40mm
  - 트 Conical Bore: 12/14 Taper
Neck Sleeves
- o BIOLOX® delta Option:
  - Manufactured from titanium alloy ■
  - 트 Neck Sleeve sizes: Short, Medium, Long, and Extra-long
  - . Conical Bore: 16/18 External Taper, 12/14 Internal Taper

C. Substantial Equivalence Information

The design features and materials of the BIOLOX® delta Option and Extra-long Heads are substantially equivalent to those of the predicate devices cleared under K130376 and K072656. The indications of the subject devices are identical to the predicates. The fundamental scientific technology of the subject devices has not changed relative to the predicate devices. The safety and effectiveness of subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

D. Nonclinical Testing

The subject BIOLOX® delta Option femoral heads were evaluated mechanically for static (or pre-fatigue) burst strength and post-fatigue burst strength.

The subject devices were evaluated for the stability of the taper system subjected to traction forces between the BIOLOX® delta Option femoral head and BIOLOX® delta Option neck sleeve by conducting an axial pull off test to measure distraction forces.

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Image /page/5/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" underneath in red. Below the logo is the text "MicroPort Orthopedics Inc."

Rotational stability tests were also performed to measure the torque required to twist the BIOLOX® delta Option femoral head on the tapers.

Lastly, the subject devices were tested for fretting corrosion of the BIOLOX® delta Option sleeve and tapers of the stem/neck mating components.

E. Clinical Testing

Clinical data was not provided for the subject devices.

F. Biocompatibility

Biocompatibility information for the subject devices is included in the cited Master File. The intended patient contact, materials, colorants, manufacturing steps and processing additives used in the subject implant devices are identical to those of the predicate and reference devices. Therefore, additional biocompatibility testing was not completed on the subject devices.

The subject devices are implanted using existing specialized trial and impactor instruments, for which colorant and biocompatibility information were reviewed by FDA in K170444.

G. Component and Accessory Compatibility

Tables 1 and 2 show the compatibility of the subject devices with previously cleared MicroPort Orthopedics products.

Table 1. Compatible Shells and Liners, Including 510(k) information

510(k)	Device Name
K061547	DYNASTY® Beaded Shells and Liners
K070785	DYNASTY® Beaded Shells and Liners
K082924	DYNASTY® BIOFOAM® Shells and Liners
K122382	DYNASTY® BIOFOAM® Shells and Liners
K142119	PROCOTYL® L Beaded Shells and Liners
K170444	PROCOTYL® PRIME Shell and Liners
K171181	PROCOTYL® PRIME E-CLASS™ Shells and Liners

Table 2. Compatible Femoral Components, Including 510(k) Information

510(k)	Device Name
K003016	PRO-FEMUR R
K012091	PRO-FEMUR
K021346	STEM HIP REPLACEMENT SYSTEM
K041114	PROFEMUR TAPERED HIP STEM
K041586	PROFEMUR S HIP STEM
K051995	PROFEMUR RENAISSANCE HIP STEM
K052915	PROFEMUR XTR HIP STEM
K053588	PROFEMUR LX HIP STEM
K060358	PROFEMUR TL HIP STEM

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Image /page/6/Picture/1 description: The image contains the logo for MicroPort Orthopedics Inc. The logo features a blue square with rounded corners and a red star inside. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. The text "MicroPort Orthopedics Inc." is below the logo.

K080663	PROFEMUR LX REVISION 5/8 COATED HIP STEM
K081090	PROFEMUR LX 5/8 COATED HIP STEM
K091423	PROFEMUR HIP SYSTEM MODULAR NECKS
K100866	PROFEMUR HIP SYSTEM MODULAR NECKS
K110399	GLADIATOR PLASMA CLASSIC HIP STEM
K111698	PROFEMUR(R) E CEMENTLESS HIP STEM
K111699	PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
K111910	GLADIATOR HIP STEM
K112080	PRESERVE HIP STEM
K112150	PROFEMUR GLADIATOR HA HIP STEM
K121221	PROFEMUR Z REVISION HIP STEM
K123434	PROFEMUR Z CLASSIC STEM
K123688	PROFEMUR TL CLASSIC STEM
K130984	PROFEMUR RENAISSANCE CLASSIC STEM
K140676	PROFEMUR TL CLASSIC LONG NECK HIP STEMS
K141235	PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
K150133	PROFEMUR PRESERVE SIZE 1-3 HIP STEMS
K150302	PROFEMUR PRESERVE CLASSIC STEM

H. Conclusions

The safety and effectiveness of the BIOLOX® delta Option and Extra-long Heads are adequately supported by the substantial equivalence information, materials information, and nonclinical testing data provided within this premarket notification.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.